Guilford, CT, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Hyperfine is initiating a global research program supported by a $1.6 million grant from the Bill & Melinda Gates Foundation to investigate whether portable magnetic resonance imaging (MRI) in low-resource countries without readily-accessible MRI technology can identify and potentially mitigate labor- and delivery-related brain damage resulting in HIE (hypoxic ischemic encephalopathy) in infants.
HIE is caused by birth asphyxia or limited blood flow to the brain, often occurring before or during birth, and is estimated to affect about 1.5 births per 1,000 live births.i According to the World Health Organization, it is the fifth leading cause of death worldwide in children under the age of 5,ii with the incidence of HIE higher in countries with limited resources.iii The most important current treatment for HIE is therapeutic hypothermia (cooling the infant’s brain), and current guidelines recommend that this treatment commence as soon as possible after the injury and within 6 hours of birth.iv Swoop™ portable MR imaging could enable rapid identification of HIE, providing time-critical decision-making support to deploy therapeutic hypothermia as soon as possible.
The foundation’s interest in the program, as part of its focus on Maternal, Newborn and Child Health, stems from the utility and applicability of low-field MR imaging to deliver accessible neuroimages that could identify birth asphyxia-related brain injuries and provide an opportunity for therapeutic intervention. In addition, portable MR imaging technology could assess brain volume and detect malnutrition in the first year of life, providing an opportunity for early nutritional interventions.
The foundation’s grant will support the deployment of 20 Swoop™ devices to investigators and will fund the program for the next two years. Ten devices will be sent to leadership sites to validate protocols for research programs and explore data outcomes, and another ten devices will be sent to lower resource settings in which birth-related brain injuries and malnutrition are persistent and access to MRI technology is limited. The Swoop™ devices will start shipping to identified sites in 2020, and all 20 systems will be delivered by the Spring of 2021.
”The impact of maternal anaemia, malnutrition, infection and birth-related brain injury in less developed countries is very worrying,” commented the principal investigator, Professor Steve Williams from Kings College London. “By creating unprecedented access to this pioneering technology, we will learn to assess and manage brain health for a wide range of clinical conditions. We are extremely enthusiastic about the potential impact this could have on babies and their families in the future.”
“We are a mission in the form of a company — to make MR imaging accessible and affordable to everyone — and this research program is a perfect example of realizing that vision,” commented Dr. Khan Siddiqui, Hyperfine’s Chief Medical Officer. “We are so appreciative of the support from the foundation to help us improve the lives of mothers and children in underdeveloped countries by providing immediate and affordable access to the technology they need to improve patient outcomes.”
ABOUT MR IMAGING and the Swoop™ Portable MRI System
Magnetic Resonance Imaging (MRI) uses a magnetic field, radio waves, and a computer to produce detailed pictures of the body's internal structures that are clearer, more detailed, and more likely in some instances to identify and accurately characterize disease than other imaging methods. However, fixed MRI systems can be inconvenient and inaccessible for providers and patients, particularly when time is critical. Transport to the MR suite demands complicated scheduling coordination, moving patients, and, often, 4- to 6-hour patient backlogs — all of which compromise the utility of MRI as a diagnostic tool in time-sensitive settings, such as intensive care units and emergency rooms. Furthermore, high capital investments, electrical power needs, and significant maintenance requirements present barriers to adoption across all populations, acutely so for developing countries and rural geographies.
Hyperfine’s Swoop™ Portable MR Imaging System is designed to address the limitations of current imaging technologies and make MRI accessible anytime, anywhere, to any patient. Swoop™ wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled by an Apple iPad®. Images that display the internal structure of the head are captured at the patient’s bedside, with results in minutes, enabling critical decision-making capabilities across a variety of clinical settings, such as neurointensive care units, emergency departments, pediatrics, ambulatory outpatient surgery centers and more. Designed as a complementary system to traditional MRIs, new users can be trained on system operation, device navigation and device safety in about 30 minutes, helping clinicians streamline workflow. The complete Hyperfine system costs less than the annual service contract alone for most current MRI systems.
About Hyperfine Research
Hyperfine lives to make MR imaging available to everyone. The Swoop™ Portable MR Imaging System is the result of a total rethink of MR’s potential in the healthcare landscape. What if MR imaging didn’t require a dedicated suite, extensive training or expensive upkeep? Let’s use the wonders of high-field MRI for the appropriate patients, and deploy Swoop™ at the point-of-care for everyone else. Hyperfine received market-ready FDA clearance for its portable MR imaging for the brain and head of patients of all ages in August 2020, and has been recognized as the Best New Radiology Vendor of 2020 by Aunt Minnie and with a Best Practices Product Innovation Award from Frost & Sullivan since the product launched. Hyperfine is part of 4Catalyzer, a health technology incubator with facilities in CT, NY, CA and Taiwan. www.hyperfine.io.
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i Kurinczuk, J. J., White-Koning, M., & Badawi, N. (2010). Epidemiology of neonatal encephalopathy and hypoxic–ischaemic encephalopathy. Early human development, 86(6), 329-338.
ii Hypoxic-Ischemic Encephalopathy. (2019, February 03). Retrieved March 28, 2019, from https://emedicine.medscape.com/article/973501-overview#a2
iii Zanelli, S. A., Stanley, D. P., & Kaufman, D. A. (n.d.). What is the global prevalence of hypoxic-ischemic encephalopathy (HIE)? Retrieved March 28, 2019, from https://www.medscape.com/answers/973501-106461/what-is-the-global-prevalence-of-hypoxic-ischemic-encephalopathy-hie
iv The Academica Medical Center Patient Safety Organization (AMC PSO) Neonatal Encephalopathy Task Force. (2016). Therapeutic Hypothermia in Neonates: Recommendations of the Neonatal Encephalopathy Task Force[Pamphlet]
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